FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RF IgM (Rheumatoid Factor) ELISA
DI: 04048474027754
·
Model: EIA-2775
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RF IgM (Rheumatoid Factor) ELISA
- Primary DI
- 04048474027754
- Version / Model
- EIA-2775
- Catalog Number
- EIA-2775
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 1
- Public Version Date
- 2024-12-02
- Public Version Status
- New
- Public Device Record Key
- 9d884d8f-fe52-4c66-bfce-b315044c35ac
- Distribution End Date
- 2024-11-25
Device Description
The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM-class antibody in human sera. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Immunology | 866.5775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55107 | Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048474027754 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961277 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stop Solution | ||
| Device Size Text, specify | TMB Substrate Solution | ||
| Total Volume | 30 | Milliliter | |
| Device Size Text, specify | Conjugate | ||
| Total Volume | 100 | Milliliter | |
| Device Size Text, specify | Sample Diluent | ||
| Total Volume | 15 | Milliliter | |
| Device Size Text, specify | Calibrators | ||
| Device Size Text, specify | Wash Buffer | ||
| Total Volume | 0.5 | Milliliter | |
| Total Volume | 0.35 | Milliliter | |
| Device Size Text, specify | Negative Control | ||
| Device Size Text, specify | Positive Control |